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In this ISSUE

The Success of Cell Therapies Will Depend on Automation

Biosimilars Overcome Hurdles, Move into Mainstream

Brexit Challenges Still Failing to Convince the UK of Grim Realities

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mHEALTH
The Lupus Research Alliance and Pfizer Descend into mHealth Studies
This Q&A discusses how the movement in making studies more patient-centric continues, and Pfizer is now implementing its own mHealth study in Lupus.
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Clinical Trial Simulation: An Efficient Tool for Improved Study Designs, Dose Selection and Go/No-go Investment Decisions
Live Webcast: Tuesday, September 19 at 2:00pm BST and Thursday, September 28 at 10am EDT
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Quality Assurance
High Quality ECG Recording Assurance
This article discusses the importance of good patient preparation, lead hook-up, and the quality checks that can be performed to ascertain that an ECG is of good quality.
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Minimal Residual Disease Detection: Key Considerations for Clinical Development in Oncology
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Patient Centricity
The “Pre” Clinical Conversation: Dialogue Strategies Uncovered
Audio study analyzes the communicative exchange factors between doctors and patients before enrollment—to better inform recruitment tactics.
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Shortening Biosimilar Development: A Case Study Integrating Early Clinical (Phase I) with late phase (Phase III) Biosimilars Development
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Study Start-Up
Building Quality into Study Startup
The ICH-GCP E6(R2) includes a section dedicated to risk-based Quality Management, and states that the sponsor should implement a system to manage quality throughout all stages of the trial process, including the beginning.
... /Read more/
Protocol Design
Data Shows Pharma is not Fully Incorporating Patient Endpoints Study Design
In this article, we will analyze themes from asthma patient conversations via HealthUnlocked, an online healthcare social network, and compare these themes to asthma clinical trial endpoints from large pharma studies.
... /Read more/
Calendar
/ Transformative Trial Models & Engagement 8/22-8/23 /
/ Global Risk-Based Monitoring 9/14-9/15 /
/ Interactive Response Technologies in Clinical Trials 2017 10/26-10/27 /


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A New Paradigm: Cutting-edge Processes and Analytics in Site and Patient Selection
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Lisa Henderson
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Capturing Continuous Glucose Monitoring Advantages
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Mike Tessalone
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